Deaths during clinical trials are increasing in India in the recent years even as the country emerges to be one of the most sought-after destinations of human studies of experimental medicines. What are the ethical issues involved here? Despite of so many controversies and concerns about the Clinical Trials, why do governments allow them? Discuss.
In recent years, India has emerged as a favoured destination for clinical trials. However, they have been rash and risky, opaque and often in violation of ethics. These violations include testing on vulnerable and marginalized groups (for example children who are not likely to benefit from the results of the research) and without taking their proper informed consent. The Drugs and Cosmetics Act mandates drug companies wanting to recruit volunteers or patients to participate in clinical trials to get their “informed consent”. But the situation gets complicated when people are not literate or do not understand the language in the form. To address this, forms are prepared in different languages and participants are asked to explain back to the recruiters what they have understood. But despite this, exploitation and procedural irregularities have lowered the credibility of such trials in the public’s mind. This necessitates the need for overhaul of the regulatory system.
Clinical trials are allowed so that medicines can be tailored to the diseases of the local population. Further, domestic scientists get an exposure to the global scientific practices in local environment. Further, the patients such as those for whom no other medicine can work, might opt to participate in trial of a medicine which is near its market launch. The importance of clinical trials lies in the fact that out of 10 thousand substances identified as potential drugs, only 10 make it to human clinical trials and only 1 may be finally launched in market.
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